International Journal of Surgery 21 (2015) 75e81
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Early implementation of Enhanced Recovery After Surgery (ERAS®) protocol e Compliance improves outcomes: A prospective cohort study Michał Pe˛ dziwiatr a, b, *, Mikhail Kisialeuski a, b, Mateusz Wierdak a, b, Maciej Stanek a, b, Michał Natkaniec a, b, Maciej Matłok a, b, Piotr Major a, b, Piotr Małczak c, ski a, b Andrzej Budzyn a
2nd Department of General Surgery, Jagiellonian University, Krakow, Poland w, Poland Department of Endoscopic, Metabolic and Soft Tissue Tumor Surgery, Kopernika 21, 31-501 Krako c w, Poland Students' Scientific Society of 2nd Department of General Surgery, Jagiellonian University, Kopernika 21, 31-501 Krako b
h i g h l i g h t s Implementation of ERAS protocol reduces postoperative complications and shortens length of stay. Introducing the ERAS protocol is however a gradual process. It is possible only through close cooperation, continuous education and evaluation.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 17 February 2015 Received in revised form 29 March 2015 Accepted 28 June 2015 Available online 29 July 2015
Enhanced Recovery After Surgery protocol in colorectal surgery allows shortening length of hospital stay and reducing complication rate. Despite the clear guidelines and conclusive evidence their full implementation and putting them into daily practice meets certain difficulties, especially in the early stage. The aim of the study was to analyse the course of implementation of the ERAS protocol into daily practice on the basis of adherence to the protocol. Group included 92 patients (43F/49M) with colorectal cancer submitted to laparoscopic resection during the years 2013-2014. Perioperative care in all of them based on ERAS protocol consisting of 16 items. Its principles and discharge criteria were based on the guidelines of the ERAS Society guidelines. The entire analysed group of patients was divided into 3 subgroups (30 patients) depending on the time from ERAS protocol implementation. We analysed the compliance with the protocol and its influence on length of hospital stay, postoperative complications and readmission rate in different subgroups. The average compliance with the protocol differed significantly between groups and was 65% in group 1, 83.9% in group 2 and 89.6% in group 3. The compliance with subsequent protocol elements was different. The length of stay and complication rate was statistically different in analysed subgroups. The whole group demonstrated an inverse correlation between compliance and length of stay. This analysis leads to the conclusion that the introduction of the ERAS protocol is a gradual process, and its compliance at the level of 80% or more requires at least 30 patients and the period of about 6 months. The initial derogation from the assumed proceedings is inevitable and should not discourage further action. Particular emphasis in the initial stage should be put on continuous training of personnel of all specialties and continuous evaluation of the results. © 2015 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Limited. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: Enhanced recovery after surgery Laparoscopy Colorectal cancer Length of stay
1. Introduction * Corresponding author. 2nd Department of General Surgery, Jagiellonian University, Krakow, Poland. E-mail address: [email protected] (M. Pe˛ dziwiatr).
The advantages of the Enhanced Recovery After Surgery
http://dx.doi.org/10.1016/j.ijsu.2015.06.087 1743-9191/© 2015 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Limited. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
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M. Pe˛ dziwiatr et al. / International Journal of Surgery 21 (2015) 75e81
protocol in colorectal surgery are now very well documented in literature [1e4]. These include shorter hospital stay and reduced number of postoperative complications [5]. Randomized controlled trials confirmed the safety of ERAS programmes [6e10]. In 2013, guidelines on perioperative care for patients after resection of the colon and rectum were published [2,3]. Despite the clear guidelines and conclusive evidence on the legitimacy of their use, their full implementation and putting them into daily practice meets certain difficulties [11e13]. Firstly, their interpretation leaves a wide margin of discretion, which makes the individual elements of the protocol, and their number vary depending on the surgical department size and profile [14e16]. Secondly, effective implementation of ERAS requires close collaboration of a multidisciplinary team consisting of surgeons, anaesthetists, nurses, physiotherapists and dieticians. The specificity of a comprehensive approach to perioperative care leads to a situation when individual member breaking out from a large team can prevent the protocol's full implementation [12]. It turns out that even in hospitals where the ERAS protocol has been implemented for some time, adherence to some of its elements is incomplete [17,18]. Although there are several studies on the compliance with ERAS programmes, little attention was paid to the analysis of the early stages after introducing it into general practice. 2. Aim The aim of the study was to analyse the course of implementation of the ERAS protocol into daily practice on the basis of adherence to the protocol. We assessed if compliance influences the length of hospital stay (LOS), postoperative complications and readmission rate.
protocol, additional training for staff was conducted, at the same time expanding the team and appointing the ERAS nurse responsible e.g. for preparing patients to stay in the hospital, care during their stay, stoma care education, assistance in complying with the protocol, and, after discharge from hospital, monitoring all patients via telephone. Currently, the team responsible for monitoring the implementation of the protocol consists of 10 people (5 surgeons, 2 anaesthetists, 2 nurses, physiotherapist and a dietician). While assessing compliance, two parameters were analysed: the percentage of the entire protocol implementation for each patient, and the degree of implementation of each of its elements in certain periods of time (30 consecutive patients). For most elements a simple assessment was possible, based on a yes/no answer. The implementation of the item involving no bowel preparation consisted in the lack of bowel preparation in the case of surgery of the colon and upper part of the rectum, and preparation in the case of total mesorectal excision (TME) with defunctioning loop ileostomy. In the case of restrictive fluid therapy, the cut-off point was less 2500 ml intravenous fluids on the day of surgery. In case of opioids, the element was considered implemented if no opioid were administered postoperatively. The use of epidural anaesthesia (which was used mainly in the initial period) or transversus abdominis plane (TAP) block instead (used routinely in later stages) was treated equivalently. Primary outcome was the compliance with the protocol and its influence on length of hospital stay, postoperative complications and readmission rate in different subgroups. A complication was defined using the Clavien-Dindo classification. Readmission was identified as any patient rehospitalisation within 30 days of surgery after discharge. 3.1. Statistical analysis
3. Methods Our department is a university tertiary referral medical center. We are mostly involved in elective treatment of abdominal surgical diseases. 80% of all procedures are performed laparoscopically (colorectal, gastric, pancreatic, bariatric, hepatobiliary, splenic and adrenal surgery). We perform about 100 colorectal procedures a year, and minimally invasive access is a method of choice in case of large bowel pathology. At the beginning of 2013, it was decided to introduce the ERAS protocol for general practice in patients after colorectal surgery. At the moment it is also routinely used in patients operated due to pathology of the stomach, pancreas, liver and due to morbid obesity. The study included patients with colorectal cancer submitted to laparoscopic resection during July 2013 and June 2014. Perioperative care in all of them based on ERAS protocol consisting of 16 items (Table 1). Its principles and discharge criteria were based on the guidelines of the ERAS Society guidelines [2,3]. Before the implementation, an independent ERAS coordinator, not involved directly in the treatment process was appointed, and a series of trainings for the team was started. Further analysis excluded patients with distant metastases and patients in whom in addition to colorectal resection another multiorgan surgery was performed due to stage of the disease. The group also excluded patients with rectal cancer operated using the experimental hybrid TaTME technique (Transanal Total Mesorectal Excision), since it was introduced relatively recently. The entire analysed group of patients was divided into 3 subgroups depending on the time from ERAS protocol implementation. The coordinator was responsible for the prospective collection of data while running a continuous audit and analysis of the results every 30 consecutive patients. After his report, and after identifying problems encountered during the implementation of the ERAS
Due to the lack of normal data distribution with a normal distribution when comparing groups in terms of measurable and ordinal data, the KruskaleWallis analysis of variance test was used. Comparing groups in terms of nominal data was done using the chisquare test. The relationship between the compliance with the protocol and LOS was examined using Pearson's correlation. Statistical significance is accepted at p < 0.05. All patients were informed about the study and gave their consent before including in the study group. The study obtained the ethical approval from the local Ethics Review Committee and has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. 4. Material During the study period 104 patients underwent colorectal resection for cancer. 12 of them did not meet the inclusion criteria (Fig. 1). The study group consisted of a total of 92 patients (43 women, 49 men); the mean age was 66.6 years (27e94 years). 62 patients had colonic and 30 rectal resection. Patients were divided into 3 groups: group 1 included the first 30 patients operated on after the introduction of the ERAS protocol, group 2 included another 30 patients operated on after the second cycle of training, and group 3 consisted of 32 patients after the next audit. Demographic characteristics and the types of procedures performed in the subgroups are presented in Table 2. Subgroups were comparable to each other in terms of age, gender, body mass index (BMI), ASA (American Society of Anaesthesiologists), physical status, operative times, and the types of procedures performed (colon/rectum). We noticed however that there was a significant difference in intraoperative blood loss
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Table 1 ERAS protocol used in our unit. 1. Preoperative counselling and patient's education 2. No bowel preparation (oral lavage in the case of low rectal resection with TME and defunctioning loop ileostomy) 3. Pre-operative carbohydrate loading (400 ml of Nutricia preOp® 2 h prior surgery) 4. Antithrombotic prophylaxis (Clexane® 40 mg sc. starting in the evening prior surgery) 5. Antibiotic prophylaxis (preoperative Cefuroxime 1.5 g þ Metronidazole 0.5 g iv 30e60 min prior surgery) 6. Laparoscopic surgery 7. Balanced intravenous fluid therapy (
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Original research
Early implementation of Enhanced Recovery After Surgery (ERAS®) protocol e Compliance improves outcomes: A prospective cohort study Michał Pe˛ dziwiatr a, b, *, Mikhail Kisialeuski a, b, Mateusz Wierdak a, b, Maciej Stanek a, b, Michał Natkaniec a, b, Maciej Matłok a, b, Piotr Major a, b, Piotr Małczak c, ski a, b Andrzej Budzyn a
2nd Department of General Surgery, Jagiellonian University, Krakow, Poland w, Poland Department of Endoscopic, Metabolic and Soft Tissue Tumor Surgery, Kopernika 21, 31-501 Krako c w, Poland Students' Scientific Society of 2nd Department of General Surgery, Jagiellonian University, Kopernika 21, 31-501 Krako b
h i g h l i g h t s Implementation of ERAS protocol reduces postoperative complications and shortens length of stay. Introducing the ERAS protocol is however a gradual process. It is possible only through close cooperation, continuous education and evaluation.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 17 February 2015 Received in revised form 29 March 2015 Accepted 28 June 2015 Available online 29 July 2015
Enhanced Recovery After Surgery protocol in colorectal surgery allows shortening length of hospital stay and reducing complication rate. Despite the clear guidelines and conclusive evidence their full implementation and putting them into daily practice meets certain difficulties, especially in the early stage. The aim of the study was to analyse the course of implementation of the ERAS protocol into daily practice on the basis of adherence to the protocol. Group included 92 patients (43F/49M) with colorectal cancer submitted to laparoscopic resection during the years 2013-2014. Perioperative care in all of them based on ERAS protocol consisting of 16 items. Its principles and discharge criteria were based on the guidelines of the ERAS Society guidelines. The entire analysed group of patients was divided into 3 subgroups (30 patients) depending on the time from ERAS protocol implementation. We analysed the compliance with the protocol and its influence on length of hospital stay, postoperative complications and readmission rate in different subgroups. The average compliance with the protocol differed significantly between groups and was 65% in group 1, 83.9% in group 2 and 89.6% in group 3. The compliance with subsequent protocol elements was different. The length of stay and complication rate was statistically different in analysed subgroups. The whole group demonstrated an inverse correlation between compliance and length of stay. This analysis leads to the conclusion that the introduction of the ERAS protocol is a gradual process, and its compliance at the level of 80% or more requires at least 30 patients and the period of about 6 months. The initial derogation from the assumed proceedings is inevitable and should not discourage further action. Particular emphasis in the initial stage should be put on continuous training of personnel of all specialties and continuous evaluation of the results. © 2015 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Limited. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: Enhanced recovery after surgery Laparoscopy Colorectal cancer Length of stay
1. Introduction * Corresponding author. 2nd Department of General Surgery, Jagiellonian University, Krakow, Poland. E-mail address: [email protected] (M. Pe˛ dziwiatr).
The advantages of the Enhanced Recovery After Surgery
http://dx.doi.org/10.1016/j.ijsu.2015.06.087 1743-9191/© 2015 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Limited. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
76
M. Pe˛ dziwiatr et al. / International Journal of Surgery 21 (2015) 75e81
protocol in colorectal surgery are now very well documented in literature [1e4]. These include shorter hospital stay and reduced number of postoperative complications [5]. Randomized controlled trials confirmed the safety of ERAS programmes [6e10]. In 2013, guidelines on perioperative care for patients after resection of the colon and rectum were published [2,3]. Despite the clear guidelines and conclusive evidence on the legitimacy of their use, their full implementation and putting them into daily practice meets certain difficulties [11e13]. Firstly, their interpretation leaves a wide margin of discretion, which makes the individual elements of the protocol, and their number vary depending on the surgical department size and profile [14e16]. Secondly, effective implementation of ERAS requires close collaboration of a multidisciplinary team consisting of surgeons, anaesthetists, nurses, physiotherapists and dieticians. The specificity of a comprehensive approach to perioperative care leads to a situation when individual member breaking out from a large team can prevent the protocol's full implementation [12]. It turns out that even in hospitals where the ERAS protocol has been implemented for some time, adherence to some of its elements is incomplete [17,18]. Although there are several studies on the compliance with ERAS programmes, little attention was paid to the analysis of the early stages after introducing it into general practice. 2. Aim The aim of the study was to analyse the course of implementation of the ERAS protocol into daily practice on the basis of adherence to the protocol. We assessed if compliance influences the length of hospital stay (LOS), postoperative complications and readmission rate.
protocol, additional training for staff was conducted, at the same time expanding the team and appointing the ERAS nurse responsible e.g. for preparing patients to stay in the hospital, care during their stay, stoma care education, assistance in complying with the protocol, and, after discharge from hospital, monitoring all patients via telephone. Currently, the team responsible for monitoring the implementation of the protocol consists of 10 people (5 surgeons, 2 anaesthetists, 2 nurses, physiotherapist and a dietician). While assessing compliance, two parameters were analysed: the percentage of the entire protocol implementation for each patient, and the degree of implementation of each of its elements in certain periods of time (30 consecutive patients). For most elements a simple assessment was possible, based on a yes/no answer. The implementation of the item involving no bowel preparation consisted in the lack of bowel preparation in the case of surgery of the colon and upper part of the rectum, and preparation in the case of total mesorectal excision (TME) with defunctioning loop ileostomy. In the case of restrictive fluid therapy, the cut-off point was less 2500 ml intravenous fluids on the day of surgery. In case of opioids, the element was considered implemented if no opioid were administered postoperatively. The use of epidural anaesthesia (which was used mainly in the initial period) or transversus abdominis plane (TAP) block instead (used routinely in later stages) was treated equivalently. Primary outcome was the compliance with the protocol and its influence on length of hospital stay, postoperative complications and readmission rate in different subgroups. A complication was defined using the Clavien-Dindo classification. Readmission was identified as any patient rehospitalisation within 30 days of surgery after discharge. 3.1. Statistical analysis
3. Methods Our department is a university tertiary referral medical center. We are mostly involved in elective treatment of abdominal surgical diseases. 80% of all procedures are performed laparoscopically (colorectal, gastric, pancreatic, bariatric, hepatobiliary, splenic and adrenal surgery). We perform about 100 colorectal procedures a year, and minimally invasive access is a method of choice in case of large bowel pathology. At the beginning of 2013, it was decided to introduce the ERAS protocol for general practice in patients after colorectal surgery. At the moment it is also routinely used in patients operated due to pathology of the stomach, pancreas, liver and due to morbid obesity. The study included patients with colorectal cancer submitted to laparoscopic resection during July 2013 and June 2014. Perioperative care in all of them based on ERAS protocol consisting of 16 items (Table 1). Its principles and discharge criteria were based on the guidelines of the ERAS Society guidelines [2,3]. Before the implementation, an independent ERAS coordinator, not involved directly in the treatment process was appointed, and a series of trainings for the team was started. Further analysis excluded patients with distant metastases and patients in whom in addition to colorectal resection another multiorgan surgery was performed due to stage of the disease. The group also excluded patients with rectal cancer operated using the experimental hybrid TaTME technique (Transanal Total Mesorectal Excision), since it was introduced relatively recently. The entire analysed group of patients was divided into 3 subgroups depending on the time from ERAS protocol implementation. The coordinator was responsible for the prospective collection of data while running a continuous audit and analysis of the results every 30 consecutive patients. After his report, and after identifying problems encountered during the implementation of the ERAS
Due to the lack of normal data distribution with a normal distribution when comparing groups in terms of measurable and ordinal data, the KruskaleWallis analysis of variance test was used. Comparing groups in terms of nominal data was done using the chisquare test. The relationship between the compliance with the protocol and LOS was examined using Pearson's correlation. Statistical significance is accepted at p < 0.05. All patients were informed about the study and gave their consent before including in the study group. The study obtained the ethical approval from the local Ethics Review Committee and has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. 4. Material During the study period 104 patients underwent colorectal resection for cancer. 12 of them did not meet the inclusion criteria (Fig. 1). The study group consisted of a total of 92 patients (43 women, 49 men); the mean age was 66.6 years (27e94 years). 62 patients had colonic and 30 rectal resection. Patients were divided into 3 groups: group 1 included the first 30 patients operated on after the introduction of the ERAS protocol, group 2 included another 30 patients operated on after the second cycle of training, and group 3 consisted of 32 patients after the next audit. Demographic characteristics and the types of procedures performed in the subgroups are presented in Table 2. Subgroups were comparable to each other in terms of age, gender, body mass index (BMI), ASA (American Society of Anaesthesiologists), physical status, operative times, and the types of procedures performed (colon/rectum). We noticed however that there was a significant difference in intraoperative blood loss
M. Pe˛ dziwiatr et al. / International Journal of Surgery 21 (2015) 75e81
77
Table 1 ERAS protocol used in our unit. 1. Preoperative counselling and patient's education 2. No bowel preparation (oral lavage in the case of low rectal resection with TME and defunctioning loop ileostomy) 3. Pre-operative carbohydrate loading (400 ml of Nutricia preOp® 2 h prior surgery) 4. Antithrombotic prophylaxis (Clexane® 40 mg sc. starting in the evening prior surgery) 5. Antibiotic prophylaxis (preoperative Cefuroxime 1.5 g þ Metronidazole 0.5 g iv 30e60 min prior surgery) 6. Laparoscopic surgery 7. Balanced intravenous fluid therapy (
